Flexible cannula insertion device, system and process

ABSTRACT

An insertion set system includes a base configured to be secured to a patient, and a flexible tubing on the base. The flexible tubing has a distal end portion forming a cannula to be inserted into the patient. An inserter having a needle is received by the base. The needle has a channel in which the distal end portion of the flexible tubing is received. The needle is able to slide relative to the flexible tubing, to selectively withdraw the needle off of the distal end portion of the flexible tubing. The base may include a passage for fluid flow arranged transverse to the axial dimension of the distal end portion of the flexible tubing.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application claims priority from Provisional U.S. Application62/503,274, filed May 8, 2017, which is incorporated herein by referencein its entirety.

BACKGROUND

Various types of modern medical devices include or employ flexibletubing for conveying fluid media through a flow passage in the tubing.Such flexible tubing may be employed for conveying fluid media to orfrom a patient, a sensor, a pump, an insertion set or other medicaldevice, a reservoir or fluid container, an implanted or partiallyimplanted device, or the like. Such flexible tubing may be included in asensor, a pump, in insertion set or other medical device. In addition,flexible tubing may be employed for forming a cannula configured to beinserted into or partially into a patient, for example, through thepatient's skin.

Certain diseases or conditions may be treated, according to modernmedical techniques, by delivering a medication or other substance to thebody of a user, through a cannula or other tubing, either in acontinuous manner or at particular times or time intervals within anoverall time period. For example, diabetes is commonly treated bydelivering defined amounts of insulin to the user at appropriate times.Some common modes of providing insulin therapy to a user includedelivery of insulin through manually operated syringes and insulin pens.Other modern systems employ programmable fluid infusion devices (e.g.,insulin pumps) to deliver controlled amounts of insulin to a user. Incertain instances, these fluid infusion devices employ an insertion set,such as an infusion set, to be coupled to the body of a user for thedelivery of the insulin. Typically, the infusion set includes a portionof a cannula that can be, for example, inserted under the skin of theuser to deliver controlled amounts of infusion media (e.g., insulin) tothe user.

Alternatively or in addition, an insertion set with a cannula may beconfigured or employed as a sensor set, to couple a sensor to a body ofthe user. For example, a sensor set may be configured to monitor glucoselevels with a sensor set, to measure glucose levels in blood orinterstitial fluid.

In certain contexts of use, it may be desirable to employ tubing that isrelatively highly flexible or bendable, such that the tubing may becurved or bent during use. During installation or use, forces may beapplied to the tubing that cause it to curve or bend. However, as shownin demonstration diagram of FIG. 1, when a compressive force F isapplied along a length L of typical conventional tubing 1, the tubing 1can tend to buckle or kink at a bend location 3 of the tubing. In FIG.1, the tubing 1 extends from a structure 2, such as a base of aninfusion set or another medical device housing, to a surface S. When theforce F is applied (for example, by moving the medical device housingtoward the surface S, the tubing 1 is caused to bend and kink at a bendlocation 3. More specifically, at the bend location 3, the tubing wallhas collapsed inward, resulting in a reduction in the width or diameterof the flow passage in the tubing. Such kinking or collapsing of thewall of the flexible tubing can limit or cut off fluid-flow through theflow passage, which can adversely affect the operation or function ofthe medical device or system employing the tubing.

To avoid kinking or collapsing during insertion or use of a flexibletubing cannula and to improve patient comfort during insertion, aninsertion needle may be extended through the flexible tubing cannula, asshown in FIGS. 2 and 3. In FIGS. 2 and 3, the needle 4 extends throughthe flexible tubing cannula 1 and supports the flexible tubing frombending during insertion into a patient's skin, septum or otherstructure. FIG. 3 shows the flexible tubing cannula 1 and the needle 4,as viewed in the cross-section 3-3 of FIG. 2.

The needle 4 has an end 4 a that extends out from a distal end of theflexible tubing cannula 1, for piercing the patient's skin (or septum orother structure), during insertion of the flexible tubing cannula 1.Once the needle end 4 a and a portion of the length of the cannula 1have been inserted into the patient's skin (or septum or otherstructure), the needle 4 may be withdrawn from the flexible tubingcannula 1, to leave the distal end of the flexible tubing cannula 1 inthe patient (or through the septum or other structure). Accordingly, inFIGS. 2 and 4, the flexible tubing cannula 1 must have a sufficientlylarge width or diameter, to be arranged on the outside of the needle 4.As a representative example, certain infusion set cannulas 1 have anoutside diameter corresponding to a gauge of 23 G (or about 0.025-0.0255in), and certain insertion needles 4 have an outside diameter of a gaugeof 27 G or 28 G (or about 0.014 in.-0.0165 in). The distal end 1 a ofthe cannula 1 may be formed with a taper, which can add to manufacturingsteps and costs.

In certain contexts and applications of use, it may be desirable toreduce or minimize the size of the outer diameter of the flexibletubing, while still providing sufficient fluid flow capacity through thetubing. In addition, it may be desirable for the tubing to have arelatively high degree of flexibility, but also withstand kinking orbuckling when bent or curved. In addition, it may be desirable to formcannula with a relatively thin, flexible tubing. A thin, flexible tubingcan improve patient comfort during insertion and use of the cannula.

SUMMARY

One or more examples and aspects described herein relate to an insertionset device or system, or other medical devices or systems, that includeor employ a flexible tubing cannula. Certain examples include or employa cannula formed of a kink resistant fluid flow tubing. Particularexamples and aspects described herein relate to a medical deviceincluding a flexible tubing cannula and a hollow insertion needle havinga channel in which the tubing is received for insertion into a patient,septum or other structure.

According to an example, an insertion set system includes a baseconfigured to be secured to a patient. A flexible tubing is supported bythe base and has a distal end portion located external to the base. Thedistal end portion forms a cannula that is configured to be insertedinto the patient, when or while the base is secured to the patient. Theinsertion set system also includes an inserter having a needle. Theneedle has a needle channel in which at least the distal end portion ofthe flexible tubing is received. The needle is able to slide relative tothe flexible tubing, to selectively withdraw the needle off of at leastthe distal end portion of the flexible tubing.

In a further example of the above-described insertion set system, theneedle and the flexible tubing are in a first state in which at leastthe distal end portion of the flexible tubing is received in the needlechannel, and the needle is moveable along a length dimension of thedistal end portion of the flexible tubing to a second state in which theneedle is separated from the distal end portion of the flexible tubing.

A further example of the above-described insertion set system includes afluid coupling, wherein the flexible tubing has a second end oppositethe distal end portion, and wherein the second end of the flexibletubing is connected in fluid flow communication with a fluid coupling.

In a further example of the above-described insertion set system, theneedle of the inserter has a length dimension and a slot-shaped openingextending along at least a portion of the length dimension, theslot-shaped opening being open to the needle channel. In addition, theflexible tubing includes a length portion extending from the distal endportion to the second end of the flexible tubing, the length portionextending out of the needle channel, through the slot-shaped opening ofthe needle.

In a further example of the above-described insertion set system, thelength portion of the flexible tubing that extends out of the needlechannel has a bend of between about 90° and about 160° (or, inparticular examples, between about 135° and about 160°) relative to anaxial dimension A.

In a further example of the above-described insertion set system, theslot shaped opening in the needle has a first width extending from adistal end of the needle, along a first portion of the length dimensionof the needle, and a second width extending along a second portion ofthe length dimension of the needle, the second width being larger thanthe first width.

In a further example of the above-described insertion set system, thedistal end portion of the flexible tubing has a length extending alongan axial dimension of the flexible tubing. In addition, the base has achamber in fluid flow communication with the flexible tubing. Inaddition, the base has a channel extending transverse to the axialdimension, through which fluid may flow to or from the chamber.

In a further example of the above-described insertion set system, thechannel in the base extends from the chamber at an angle of betweenabout 90° and about 160° (or, in particular examples, between about 135°and about 160°) relative to the axial dimension A of the distal endportion of the flexible tubing.

A further example of the above-described insertion set system includes afirst septum on the base, at a location in alignment with the axialdimension of the flexible tubing and the chamber, wherein the needleextends through the first septum and the chamber, when the distal endportion of the flexible tubing is received in the needle channel.

A further example of the above-described insertion set system includes asecond septum located in the channel or between the channel and thechamber, the second septum configured to be pierced by a further needlefor connection of a further tubing to the channel.

In a further example of any of the above-described insertion set systemsthe flexible tubing has a further length portion extending from thedistal end portion into the base. In addition, the base includes aneedle channel through which the further length portion of the flexibletubing extends, and a collar fixing the further length portion of theflexible tubing to the base within the needle channel of the base,wherein the needle is pierced through the collar when the distal endportion of the flexible tubing is received in the needle channel.

In a further example of the above-described insertion set system, theflexible tubing has a further length portion extending from the distalend portion into the base. In addition, the example insertion set systemfurther includes a holding pin arranged and configured to abut an endportion of the further length portion of the flexible tubing and inhibitmovement of the flexible tubing with the needle while the needle isbeing withdrawn off of the distal end portion of the flexible tubing.The holding pin is moveable away from the end portion of the furtherlength of the flexible tubing, after the needle has been withdrawn offof the distal end portion of the flexible tubing.

In a further example of the above-described insertion set system, thedistal end portion of the flexible tubing has a length extending alongan axial dimension of the flexible tubing. In addition, the flexibletubing has a further length portion extending from the distal endportion into the base. In addition, the insertion set system furtherincludes a holding pin arranged and configured to abut an end portion ofthe further length portion of the flexible tubing and inhibit movementof the flexible tubing with the needle while the needle is beingwithdrawn off of the distal end portion of the flexible tubing.

In a further example of the above-described insertion set system, theholding pin comprises a rigid wire or stop structure that is fixed tothe base.

In a further example of the above-described insertion set system, theneedle of the inserter has a length dimension and a slot-shaped openingextending along at least a portion of the length dimension, theslot-shaped opening being open to the needle channel. In addition, theholding pin extends out of the needle channel, through the slot-shapedopening of the needle.

In a further example of the above-described insertion set system, theflexible tubing has a further length portion extending from the distalend portion into the base. In addition, the insertion set system furtherincludes a rigid hollow tube connected in fluid flow communication withan end portion of the further length portion of the flexible tubing andabutting the end portion of the further length portion of the flexibletubing to inhibit movement of the flexible tubing with the needle whilethe needle is being withdrawn off of the distal end portion of theflexible tubing.

In a further example of the above-described insertion set system, theneedle of the inserter has a length dimension and a slot-shaped openingextending along at least a portion of the length dimension, theslot-shaped opening being open to the needle channel. In addition, therigid hollow tube has a length portion that extends out of the needlechannel, through the slot-shaped opening of the needle.

In a further example of the above-described insertion set system, therigid hollow tube is fixed to the base and is configured to be connectedin fluid flow communication with a further tubing located at leastpartially external to the base.

An example of a method of making an insertion set system includesproviding a base configured to be secured to a patient, and supporting aflexible tubing supported by the base, with a distal end portion of theflexible tubing located external to the base, the distal end portionforming a cannula that is configured to be inserted into the patient,when or while the base is secured to the patient. The method furtherincludes receiving by the base, an inserter having a needle, the needlehaving a needle channel. The method further includes receiving at leastthe distal end portion of the flexible tubing in the channel for slidingmovement, wherein the needle is able to slide relative to the flexibletubing, to selectively withdraw the needle off of at least the distalend portion of the flexible tubing.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects and features of the present invention willbecome more apparent to those skilled in the art from the followingdetailed description of the example embodiments with reference to theaccompanying drawings, in which:

FIG. 1 is a cross-section view of a PRIOR ART tubing having a kink orbuckle.

FIG. 2 is a cross-section view of the PRIOR ART tubing of FIG. 1, on aninsertion needle.

FIG. 3 is a cross-section view of the tubing and insertion needle takenat 3-3 of FIG. 2.

FIG. 4 is a cross-section view of a flexible tubing according to anexample embodiment.

FIG. 5 is a perspective view of a length of a flexible tubing accordingto an example embodiment.

FIG. 6 is a cross-section view of the flexible tubing of FIG. 5, withinan insertion needle.

FIG. 7 is a cross-section view of the tubing and insertion needle takenat 7-7 of FIG. 6.

FIG. 8 is a cross-section view of the tubing and insertion needle takenat 8-8 of FIG. 6.

FIG. 9 is a flow chart of a method of using a tubing and insertionneedle of FIG. 6.

FIG. 10 is a cross-section view of an example insertion set device in afirst state.

FIG. 11 is a top view of the example insertion set device of FIG. 10.

FIG. 12 is a further cross-section view of the example insertion setdevice of FIG. 10 transitioning to a second state.

FIG. 13 is a further cross-section view of the example insertion setdevice of FIG. 10 in the second state.

FIG. 14 is a partial exploded, perspective view of a base of the exampleinsertion set device of FIG. 10.

FIG. 15 is a partial perspective view of a slotted needle of the exampleinsertion set device of FIG. 10.

FIG. 16 is a flow chart of a process for making an insertion set device.

FIG. 17 is a cross-section view of another example insertion set devicein a first state.

FIG. 18 shows an enlarged view of a portion of FIG. 17 identified by thecircle labeled 18 in FIG. 17.

FIG. 19 is a cross-section view of the flexible tubing, the slottedinserter needle and the collar of the example insertion set device ofFIG. 17, taken perpendicular to the axial dimension A.

FIG. 20 is a cross-section view the example insertion set device of FIG.17, in a second state.

FIG. 21 is a cross-section view of the flexible tubing, the slottedinserter needle and the collar of the example insertion set device ofFIG. 20, taken perpendicular to the axial dimension A

FIG. 22 is a cross-section view of another example insertion set devicein a first state.

FIG. 23 shows an enlarged view of a portion of FIG. 22 identified by thecircle labeled 23 in FIG. 22.

FIG. 24 shows another enlarged view of features in FIG. 23.

FIG. 25 is a cross-section view the example insertion set device of FIG.22, in a second state.

FIG. 26 is a cross-section view of another example insertion set devicein a first state.

FIG. 27 shows an enlarged view of a portion of FIG. 26 identified by thecircle labeled 27 in FIG. 26.

FIG. 28 shows another enlarged view of features in FIG. 27.

FIG. 29 is a cross-section view the example insertion set device of FIG.26, in a second state.

FIG. 30 is a cross-section view of another example insertion set devicein a first state.

FIG. 31 shows an enlarged view of a portion of FIG. 30 identified by thecircle labeled 31 in FIG. 30.

FIG. 32 shows another enlarged view of features in FIG. 31, in a secondstate.

DETAILED DESCRIPTION

Hereinafter, example embodiments will be described in more detail withreference to the accompanying drawings. The present invention, however,may be embodied in various different forms, and should not be construedas being limited to only the illustrated embodiments herein. Rather,these embodiments are provided as examples so that this disclosure willbe thorough and complete, and will fully convey the aspects and featuresof the present invention to those skilled in the art. Accordingly,processes, elements, and techniques that are not necessary to thosehaving ordinary skill in the art for a complete understanding of theaspects and features of the present invention may not be described.Unless otherwise noted, like reference numerals denote like elementsthroughout the attached drawings and the written description, and thus,descriptions thereof may not be repeated. Further, features or aspectswithin each example embodiment should typically be considered asavailable for other similar features or aspects in other exampleembodiments.

Certain terminology may be used in the following description for thepurpose of reference only, and thus are not intended to be limiting. Forexample, terms such as “top”, “bottom”, “upper”, “lower”, “above”, and“below” could be used to refer to directions in the drawings to whichreference is made. Terms such as “front”, “back”, “rear”, “side”,“outboard”, and “inboard” could be used to describe the orientationand/or location of portions of the component within a consistent butarbitrary frame of reference which is made clear by reference to thetext and the associated drawings describing the component underdiscussion. Such terminology may include the words specificallymentioned above, derivatives thereof, and words of similar import.Similarly, the terms “first”, “second”, and other such numerical termsreferring to structures do not imply a sequence or order unless clearlyindicated by the context.

It will be understood that when an element or feature is referred to asbeing “on,” “connected to,” or “coupled to” another element or layer, itcan be directly on, connected to, or coupled to the other element orfeature, or one or more intervening elements or features may be present.In addition, it will also be understood that when an element or featuresis referred to as being “between” two elements or features, it can bethe only element or feature between the two elements or features, or oneor more intervening elements or features may also be present.

The terminology used herein is for the purpose of describing particularembodiments and is not intended to be limiting of the present invention.As used herein, the singular forms “a” and “an” are intended to includethe plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises,”“comprising,” “includes,” and “including,” “has,” “have,” and “having,”when used in this specification, specify the presence of the statedfeatures, integers, steps, operations, elements, and/or components, butdo not preclude the presence or addition of one or more other features,integers, steps, operations, elements, components, and/or groupsthereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items. Expressionssuch as “at least one of,” when preceding a list of elements, modify theentire list of elements and do not modify the individual elements of thelist.

As used herein, the term “substantially,” “about,” and similar terms areused as terms of approximation and not as terms of degree, and areintended to account for the inherent variations in measured orcalculated values that would be recognized by those of ordinary skill inthe art. Further, the use of “may” when describing embodiments of thepresent invention refers to “one or more embodiments of the presentinvention.” As used herein, the terms “use,” “using,” and “used” may beconsidered synonymous with the terms “utilize,” “utilizing,” and“utilized,” respectively.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which the present invention belongs. Itwill be further understood that terms, such as those defined in commonlyused dictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the relevant art and/orthe present specification, and should not be interpreted in an idealizedor overly formal sense, unless expressly so defined herein.

Various types of modern medical devices and cannulas include or employflexible tubing for conveying fluid media. A flexible tubing forconveying fluid media and medical devices and systems that include suchflexible tubing are described, where the flexible tubing is configuredwith a relatively small outer diameter, a relatively high degree offlexibility and a relatively high resistance to kinking or buckling. Incertain examples, the flexible tubing forms a cannula configured to beinserted into or partially into a patient, such as, through thepatient's skin. The flexible tubing cannula may be included in aninsertion set or other medical device or system. Accordingly, in certainexamples, a flexible tubing as described herein is included in aninsertion set, an infusion set, a sensor device, an infusion pump orother fluid delivery system, or the like.

Also as described herein, a flexible tubing according to certainexamples described herein may be configured to fit inside of a hollowneedle, for insertion into a patient, septum or other structure. Incontrast to prior arrangements in which a tubing is arranged on theoutside of an insertion needle (as represented in FIGS. 2 and 3), aflexible tubing according to certain examples described herein may havea sufficiently small outer diameter, to fit within an open channel of aninsertion needle.

Therefore, according to certain examples described herein, a flexibletubing is configured with a reduced or minimized outer diameter(relative to certain conventional medical tubing), while still providingsufficient fluid flow capacity through the tubing, a relatively highdegree of flexibility, and a resistance to kinking or buckling when bentor curved. For example, a cannula formed from a thin, flexible tubingmay have a reduced or minimized outer diameter and relatively highflexibility (without kinking or buckling) for improved patient comfort.

A relatively high degree of flexibility in the tubing, without kinkingor buckling, can allow the tubing to bend and curve, which can improvethe ability of the tubing to be configured, fitted or adjusted in amedical device or system. Also, a flexible tubing cannula having thinouter dimension and a relatively high degree of flexibility can improvepatient comfort, by minimizing insertion trauma and allowing the cannulato flex with movement of the patient.

A flexible tubing for a medical device or system described herein mayhave an axial length dimension and a generally circular cross-sectionshape taken perpendicular to the axial length dimension, and a centralpassage through which fluid may flow. In other examples, the tubing mayhave a cross-section shape that is not a circle, such as, but notlimited to an oval, another curved shape, a polygon or a shape having acombination of curved and straight edges. The cross-section shape of thecentral passage may have a circular or another shape, and may correspondto (be the same shape as) the outer cross-section shape of the tubing.In other examples, the cross-section shape of the central passage may bea different shape relative to the outer cross-section shape of thetubing.

The material of the flexible tubing is compatible with fluids intendedto be conveyed through the tubing, and with other materials to which thetubing may come into contact or be connected, in the intendedenvironment of use. In certain examples, the flexible tubing is made ofa material that is biologically compatible, for use in contexts in whichthe flexible tubing is in contact or connected with a biological entity(such as a human patient or another biological entity), or is implantedfully or partially in the patient (or other biological entity). Incertain examples, the flexible tubing is treated in one or moreprocesses for enhancing biologically compatibility or othercompatibility for an intended environment or use, such as, but notlimited to cleaning, sterilizing, treating, or coating with Heparin, orother anticoagulant, an antibiotic, nitric-oxide or other materials, orthe like.

In certain examples the tubing is made of a material that is suitablefor medical uses, including but not limited to materials compatiblewith, and suitable for, implanting or partially implanting into apatient or other biological entity. Alternatively or in addition, thetubing material is selected to be compatible with and suitable forconveying one or more desired or predefined fluids (such as, but notlimited to insulin, cancer or AIDs treatment drugs, or othermedications, drugs or therapy fluids). Such materials may include, butare not limited to a polyether block amide (PEBA) of thermoplasticelastomer (TPE) such as PEBAX™, a polytetrafluoroethylene (PTFE), anethylene tetrafluoroethylene (ETFE), a thermoplastic polyurethane (TPU)such as PELLETHAN™, or the like. However, for other contexts andapplications of use, the tubing may be made of other materials suitableand compatible with those contexts and applications. The tubing may bemade by any suitable manufacturing process including, but not limited toextrusion, molding, machining or the like.

An example of a flexible tubing 10 having a circular cross-section shapedefining an axial dimension A, is shown in FIGS. 4 and 5. In FIG. 4, theflexible tubing 10 extends from or through a housing or other structureof a medical device 12, and has a length portion that is bent. In FIG.5, a length L of the flexible tubing 10 is shown.

The flexible tubing 10 has a central channel or passage 14, throughwhich fluid may flow. The fluid flow passage 14 extends along the lengthL of the tubing 10, and shares the same axis A of the tubing 10. Asshown in FIG. 5, the tubing 10 has an outer peripheral surface 16, aninner surface (the outer surface of the fluid flow passage 14), and athickness t between the outer peripheral surface 16 and the innersurface (outer surface of the fluid flow passage 14). The tubing 10 hasan inner radius r (the radius of the fluid flow passage 14) and an outerradius R (the radius of the outer peripheral surface 16).

In certain examples, the flexible tubing 10 is configured to have arelatively high L/R length-to-outer-radius ratio (or slenderness ratio),to be sufficiently flexible and kink resistant. In certain examples, theratio R/r (between the outer radius R and the inner radius r) isincreased or maximized, to increase the flexibility of the tubing 10. Inparticular examples, the L/R is selected to be sufficiently high (indimensions suitable for the context of use) to increase or maximize thekink resistance of the tubing, and also the ratio R/r is selected to besufficiently high (in dimensions suitable for the context of use), toincrease or maximize the flexibility of the tubing.

In addition to increasing or maximizing one or both of the ratios L/Rand R/r of the tubing (in dimensions suitable for the context of use ofthe tubing), it may be beneficial for certain applications of use toreduce or minimize the outer radius R of the flexible tubing, whilestill allowing for sufficient fluid flow volume or pressure (or both). Athinner tubing may be able to fit into narrow spaces such as, but notlimited to an inner passage of a hollow needle. A thinner tubing mayprovide a more comfortable cannula or other implantable or partiallyimplantable device. Also, if the slenderness ratio L/R is too small, thetubing can have a tendency to kink or buckle along the length L.

Accordingly, in particular examples, a relatively thin tubing that isboth flexible and resistant to kinking is configured of a PEBAX, PTFE,or other suitable material, and has an L/R ratio that is equal to orgreater than 34.8. Alternatively or in addition, the tubing has an R/rratio that is equal to or greater than 1.5. In particular examples, theL/R ratio is between about 34.889 and about 78.667. In particularexamples, the R/r ratio is between about 1.5 and about 1.8.

A flexible tubing having such dimensions can have an improvedflexibility and resistance to kinking or buckling, as compared totypical medical grade tubing and cannula tubing. In addition, a flexibletubing having such dimensions may be configured relatively thin, forexample, with an outer radius of about 0.0045 inch (0.1143 mm) or less.

Thus, in certain examples, a tubing 10 made of a PEBA of other TPE suchas PEBAX™, or a PTFE (or a combination of those materials) has an outerradius of about 0.1143 mm. (0.0045 inch) and, thus, has an inner radiusof about 0.127 mm. (0.0025 inch) (applying the above-noted R/r ratio of1.8), and a length (or length portion) L in the range of about 6 mm. toabout 9 mm. (applying the above L/R ratio ranges), as shown in Table 1.In other examples, the outer radius is about 0.1143 mm. (0.0045 inch)and the inner radius is about 0.0762 mm. (0.003 inch) (applying theabove-noted R/r ratio of 1.5, and a length (or length portion) L in therange of about 4 mm. to about 5 mm. (applying the above L/R ratioranges), as shown in Table 1.

TABLE 1 Length R r L/R R/r 4 mm. 0.1143 mm. 0.0762 mm. 34.889 1.50(0.157 inch) (0.0045 inch)  (0.003 inch) 5 mm. 0.1143 mm. 0.0762 mm.43.778 1.50 (0.197 inch) (0.0045 inch)  (0.003 inch) 6 mm. 0.1143 mm. 0.127 mm. 54.444 1.80 (0.236 inch) (0.0045 inch) (0.0025 inch) 9 mm.0.1143 mm.  0.127 mm. 78.667 1.80 (0.354 inch) (0.0045 inch) (0.0025inch)

In the table 1 examples, the tubing 10 can be relatively flexible, whilehaving a relatively high resistance to kinking or buckling (collapsingof the outer wall) when bent along a length portion of length L.

In addition, the flexible tubing 10 can be configured relatively thin(can have a relatively small outer diameter). By reducing or minimizingthe size of the outer diameter of the flexible tubing 10, variousadvantages are available such as, but not limited to improving patientcomfort, and reducing the size and the weight of a medical device orsystem that includes the tubing.

In certain examples as shown in FIGS. 6 and 7, the flexible tubing 10 isconfigured to be sufficiently thin, to extend through a central channelof a hollow insertion needle 20. FIG. 7 shows the flexible tubing andthe insertion needle 20, as viewed in the cross-section 7-7 of FIG. 6.The insertion needle 20 has a hollow, central channel configured toreceive the flexible tubing 10. When the flexible tubing 10 is receivedwithin the hollow channel of the insertion needle 20, the insertionneedle 20 and flexible tubing 10 are moveable relative to each other inthe axial direction A, for example, to allow the needle to slide off ofthe flexible tubing 10, or to allow the flexible tubing to slide out ofthe needle 30.

In particular examples, a cannula composed of the flexible tubing 10 canbe received within the channel of the hollow needle 20, with the distalend 10 a of the flexible tubing 10 located at least partially inside ofthe channel of the hollow needle 20 as shown in FIGS. 6 and 7. When theflexible tubing 10 is received in the channel, the needle 20 is slidablerelative to the flexible tubing 10, in the axial direction. In thatarrangement, the hollow needle 20 may be inserted into a patient's skin(or a septum or other structure), a sufficient distance to place thedistal end of the flexible tubing 10 in the patient (or through theseptum or other structure). The hollow needle 20 provides additionalrigidity and can have a pointed or sharp tip, to assist in piercing thepatient's skin (or septum or other structure) during insertion. Once thehollow needle 20 containing the flexible tubing 10 is inserted into (orpartially into) the patient's skin (or a septum or other structure), thehollow needle 20 may be slid off of some or all of the flexible tubing10, while leaving the distal end 10 a of the flexible tubing 10 in placein the patient (or through the septum or other structure).

By locating a cannula composed of flexible tubing 10 inside of thehollow needle 20, various advantages are available such as, but notlimited to reducing insertion force needed to insert the cannula andimproving patient comfort. In addition, the distal end 10 a of theflexible tubing 10 need not be tapered, which can help to reduce orminimize manufacturing costs as compared to tapered tubing. Also, astraight cylindrical tip, without taper, can more evenly distributecompression stresses compared to tubing configurations with a tapereddistal end.

In the example of FIGS. 6 and 7, the distal end portion 20 a of theneedle 20 has a slot or opening along the axial dimension A of the sidewall of the needle. Accordingly, the cross-section shape of the distalend portion 20 a of the needle (at the cross-section 7-7 in FIG. 6) hasa slotted circle or “C” shape, as shown in FIG. 7. The slot or openingin the side wall of the needle 20 extends from the distal end 20 b ofthe needle 20, along at least a portion of the axial length of theneedle 20. Accordingly, when the needle 20 is moved in the axialdirection relative to the tubing 10, to slide off (or partially off) ofthe tubing 10, the distal end portion 20 a of the needle 20 may be slidoff of at least a portion of the tubing 10, leaving the distal end 10 aof the tubing 10 outside of the needle 20.

In the example in FIG. 6, the slot or opening in the side wall of theneedle 20 extends a portion, but not the entire axial length of theneedle 20, such that a cross-section shape of the needle 20 at 8-8 inFIG. 6 has a shape as shown in FIG. 8, where that section of the needlehas a fully cylindrical shape. In other examples, the slot or opening inthe side wall of the needle 20 extends the entire axial length (orsubstantially the entire axial length) of the needle 20, such that across-section shape of the needle 20 is similar to that shown in FIG. 7,along the entire (or substantially the entire) axial length of theneedle 20. In further examples, the hollow needle 20 may have a smallopening or slot at its distal end (or sharp end) through which thedistal end portion of the flexible tubing 10 may extend as the needle 20is withdrawn, but has a full cylindrical shape (with a cross sectionshape as shown in FIG. 8) along the rest of the length of the needle.

An example process 30 of using a flexible tubing cannula is describedwith reference to FIG. 9. The process 30 includes receiving a tubing ina needle (at 32). The tubing may be received in a channel of a needle asdescribed herein with respect to the flexible tubing 10 received withinthe central channel of the slotted needle 20.

The process 30 also includes inserting the needle and tubing (at 34).The needle and tubing may be inserted into a patient, septum or otherstructure, as described herein with respect to inserting the needle 20while the tubing 10 is located within the central channel of the needle20.

The process 30 also includes withdrawing the needle while the tubing isheld in an inserted state (at 36). The needle may be slid off of thetubing as described herein with respect to sliding the needle 20 in theaxial direction relative to the tubing 10.

The process 30 also includes coupling the tubing to a device, fluidsource or a fluid receptacle (at 38). For example, the tubing may becoupled to a medical device, a fluid source or a fluid receptacle at anystage of the process 30. In certain examples, the tubing has a secondend (or port) coupled to a fluid source, for receiving fluid to beconveyed through the tubing to a patient (or device to which the distalend of the tubing is connected). The fluid source may include, but isnot limited to an infusion pump, fluid-containing reservoir, or otherfluid delivery system. In other examples, the second end (or port) ofthe tubing may be coupled to a reservoir or volume for receiving fluidfrom the patient (or from the device to which the distal end of thetubing is connected). For example, the reservoir or volume may be aportion of a sensor that receives fluid from a patient (or from adevice) and senses detectable parameters of the fluid.

In other examples, a flexible tubing 10 or a hollow needle 20 with aflexible tubing 10 may be employed in other suitable processes. Insystems, devices and process in which the flexible tubing 10 is receivedwithin the central channel of the hollow needle 20 for insertion,various advantages may be available, including but not limited to anability to minimize or reduce the outer diameter of the flexible tubing10 (for example, relative to a tubing and inserter configuration ofFIGS. 1-3, which can significantly improve patient comfort duringinsertion and use when the flexible tubing 10 forms a cannula. Inaddition, the flexible tubing 10 may have a single, constant diameter,which can reduce manufacturing costs and improve patient comfort. Also,stress on the flexible tubing 10 before and during insertion may bereduced or minimized (for example, relative to a tubing and inserterconfiguration of FIGS. 1-3 in which the tubing 1 is located on theoutside of the inserter needle 4).

Further examples of slotted needle configurations, insertion sets andother medical devices that include or employ slotted needles aredescribed with reference to FIGS. 10-32. The systems and devices inFIGS. 10-32 may include or employ a kink resistant, flexible tubing 10as described herein with reference to FIGS. 4-8. However, other examplesof such systems and devices may employ other suitable tubing or flexibletubing. The insertion sets may be infusion sets configured to couple to(or be part of) an infusion system for delivering a fluid media to apatient or other entity, through the flexible tubing, for example, froman infusion pump, reservoir or other delivery device. Alternatively orin addition, the insertion sets may be configured to couple to (or bepart of) a sensor system for delivering a fluid media from a patient oranother entity, through the flexible tubing, for example, to a sensingdevice. In other examples, the insertion sets may be configured tocouple to (or be part of) other systems that deliver fluid media to orfrom a patient or another entity.

An example of an insertion set device 40 having a cannula formed with orof a flexible tubing 10 (or other suitable tubing) is described withreference to FIGS. 10-14. FIGS. 10 and 11 show a cross-section side viewand a top view, respectively, of the insertion set device 40, in a firststate. The cross-section view in FIG. 10 is taken along 10-10 of FIG.11. FIG. 12 shows a similar cross-section view of the insertion setdevice 40, transitioning from the first state to a second state. FIG. 13shows a similar cross-section view of the insertion set device 40, inthe second state.

The insertion set device 40 includes a base 42 and an inserter 44. Inthe first state, as shown in FIGS. 10 and 11, the inserter 44 isreceived and supported by the base 42, but is removable from the base 42by moving the inserter 44 (e.g., lifting upward in FIG. 10) from thebase 42 in the axial direction A (or otherwise moving the inserter 44and base 42 apart in the axial direction A). In FIG. 12, the inserter 44is partially lifted from the base 42. In the second state, as shown inFIG. 13, the inserter 44 is fully separated (fully lifted) from the base42.

The base 42 has a surface 46 configured to abut against or secure to theskin of a patient, or to a surface of a septum or other device to whichthe cannula of flexible tubing 10 is to be inserted. In particularexamples, one or more mechanisms for securing the surface 46 to thepatient, septum or other device may be included on the base 42, such as,but not limited to adhesive on the surface 46, straps, suture tabs oropenings, or the like.

The base 42 may include one or more parts that form a housing forholding or containing the flexible tubing 10 and a coupling 48. In theexample of FIG. 14, the base 42 includes two parts that may be separatedto allow access to internal components, and that couple together to forma disc-shaped housing that contains the internal components. Anysuitable mechanism may be employed to couple the base parts together toform the housing of the base 42, including, but not limited to shaftprotrusions 43 on one part that fit into corresponding apertures inanother part, in a friction-fit manner. Alternatively or in addition,other suitable mechanism may be employed to couple the base partstogether, including, but not limited to adhesives, screws or otherthreaded fasteners, friction fitted groove and rib configurations, orthe like. In other examples, the base 42 may include a single parthousing, or more than two parts that form a housing, the housing mayhave other suitable disc or non-disc shapes, and other suitableconnection structures may be employed for connecting the housing parts.In yet other examples, the base 42 may have a be configured with ahollow or partially hollow interior, for example, in a clamshellconfiguration. In other examples, the base 42 may have other suitableconfigurations that holds and encloses a portion of the flexible tubing10 and a portion of the coupling 48.

The base 42 shown in FIGS. 10-14 has a generally rounded disc shape,with a rounded top edge. However, in other examples, the base 42 mayhave other suitable shapes. The base 42 may be made of any suitablematerial, such as, but not limited to plastic, metal, ceramic, compositematerial, or the like. In particular examples, the base 42 is agenerally rigid structure. In other examples, the base 42 may havesufficient rigidity to hold its shape, but may be made of materialhaving some flexibility or malleability, such as but not limited to asoft plastic, a rubber or rubber-like material, or the like.

The base 42 has a first opening 42 a in the surface 46 (the bottomsurface in FIGS. 10-14) and includes a needle passage 50 extending fromthe first opening 42 a, to a second opening 42 b in a surface of thebase 42 (the top surface in FIGS. 10-14) opposite to the surface 46. Thepassage 50 may be formed as a channel or bore through the material ofthe base 42 as shown in FIG. 14. In further examples, the passage 50 maybe the interior channel of a tube-like structure in the base 42,extending between the first and second openings 42 a and 42 b.

The distal length portion 10 b of the tubing 10 extends out from thefirst opening 42 a in the surface 46 of the base 42, such that thedistal end 10 a of the tubing 10 is located outside of the base 42. Afurther length portion 10 c of the tubing 10 is located within the base42 and extends from the distal length portion 10 b, to the coupling 48.The further length portion 10 c has a tubing end that is connected influid flow communication with the coupling 48.

The further length portion 10 c of the flexible tubing 10 has a firstsection that extends along part of the length of the passage 50, asecond section that forms a relatively sharp bend 10 d and a thirdsection that extends from the bend 10 d to the coupling 48. The bend 10d may form a relatively sharp angle, such that the height H in the axialdimension of the base 42 (dimension between the surface 46 and theopposite facing surface) may be made relatively small or minimized. Incertain examples, the bend 10 d may be about 90°, such that the coupling48 is directed about 90° from the direction of distal length portion 10b of the tubing 10. This arrangement allows a further tubing 52 to beconnected to the coupling 48, external to the base 42, and extendoutward from the base 42 in a direction substantially parallel to andalong the surface of the patient's skin (or other surface) to which thebase 42 secures. Accordingly, the base 42 and tubing 52 may be moreeasily concealed under clothing or the like. In other examples, the bend10 d may be between about 90° and about 160° (or, in particularexamples, between about 135° and about 160°) relative to the axialdimension A.

In certain system examples, the further tubing 52 may be connected orconfigured to connect (at an end opposite to the end connected to thecoupling 48) to an infusion pump or other fluid delivery device, asensor or monitoring device, or the like. In certain examples, thefurther tubing 52 may have a tubing configuration as described hereinwith reference to the flexible tubing 10. In other examples, the furthertubing 52 may be another type of flexible tubing, a non-flexible tubing,or a combination of flexible and non-flexible tubing lengths.

The coupling 48 may be any suitable fluid coupling structure, forcoupling two tubing ends together, for fluid flow communication. Inparticular examples, the coupling 48 allows for connection anddisconnection of further tubing to the base 42. In the examples of FIGS.10-14, the coupling 48 may include an in-line tubular structure having acentral passage with an inside diameter large enough to receive an endlength portion of the third section of the tubing portion 10 c. Thecoupling 48 has an end portion 48 a located outside of the base 42, forsecuring to the further tubing 52. In the example in FIGS. 10-14,further tubing 52 has an inside diameter large enough to receive some orall of the end portion 48 a of the coupling 48. In other examples, theend portion 48 a of the coupling 48 has an inside diameter large enoughto receive an end length portion of the further tubing 52 within thecoupling 48. The end length portion of the tubing portion 10 c may befixed and sealed to the coupling 48, and the tubing 52 may be fixed andsealed to the coupling 48 by any suitable mechanism, including frictionfitting, adhesives, welds, or the like. In other examples, the coupling48 may be another suitable in-line coupling device, such as, but notlimited to a Luer Lok™ device, Luer™-slip device, slip tip device,hollow needle and septum configuration or the like.

In the example of FIGS. 12 and 13, the coupling 48 or the third sectionof the tubing (or both) are secured and fixed to the base 42. In furtherexamples, additional structure (not shown) may be included in the base42, to secure the coupling 48 and the tubing 10 to the base, in a fixedrelation. However, the distal length portion 10 b of the flexible tubing10 is sufficiently flexible to flex and bend along the distal lengthportion 10 b. In contexts in which the distal length portion 10 b formsa cannula for insertion into a patient's skin, the flexibility of thedistal length portion 10 b can provide additional comfort to thepatient, by allowing the cannula to move and flex with the patient'sskin.

As discussed above, the inserter 44 is received and supported by thebase 42, but is selectively removable from the base 42. The inserter 44includes an inserter body 53 and a slotted inserter needle 54. Theinserter body 53 may have a handle portion 53 a configured to be easilygripped by a human hand. The handle portion 53 a may include one or moresurfaces with ribs or other contour features, an added frictionmaterial, or the like, for enhancing frictional engagement and grippingby a user, tool or machine. In certain examples, the inserter body 53may include a handle 53 a or other portion configured to be gripped orotherwise secured to a separate tool or device, such as an inserterdevice (not shown) for installing (inserting) the insertion set device40 in a patient or other entity.

The inserter needle 54 has one end that is fixed in or to the inserterbody 53, and extends in the axial dimension direction A of the needle,from the inserter body 53 to an opposite, distal end 54 a. The distalend 54 a of the inserter needle 54 may have a sharp or tapered shape.The inserter needle 54 has a central channel that is open at the distalend 54 a, and a slot-shaped opening 56 into the central channel,extending from the distal end 54 a, along at least a portion of itsaxial length. In some examples, the slot-shaped opening 56 extends theentire length of the inserter needle 54. In other examples, as shown inFIG. 15, the slot-shaped opening extends from the distal end 54 a, alonga first portion 54 b of the of the length of the inserter needle 54, toa second portion 54 c of the length of the inserter needle 54, where thesecond portion 54 c has a fully cylindrical shape (hollow or solid). Theinserter needle 54 may correspond to the inserter needle 20 describedwith reference to FIGS. 6 and 7. In other examples, the inserter needle54 may have other suitable slotted configurations for functioning in themanner described herein.

In certain examples, the slot-shaped opening 56 has a first segment 56 awith a first slot width, and a second segment 56 b with a second slotwidth that is larger than the first slot width, as shown in FIG. 15. Aslotted inserter needle 54 having multiple widths such as shown in FIG.15 can help simplify manufacturing, assembly or set-up procedures, asdescribed below. In certain contexts such simplifying of procedures mayhelp to reduce costs of manufacture and assembly of the insertion setdevice 40. In other examples, the slot-shaped opening 56 may have aconstant width along its entire length.

The slotted inserter needle 54 may be made of any suitable, rigidmaterial such as, but not limited to, stainless steel or other metal,ceramic, composite material, plastic, or the like. In certain examples,the slotted inserter needle is made of a material that is biologicallycompatible, for use in contexts in which the inserter needle is to be incontact or connected with a biological entity (such as a human patientor another biological entity). In certain examples, the inserter needleis treated in one or more processes for enhancing biologicallycompatibility or other compatibility for an intended environment or use,such as, but not limited to cleaning, sterilizing, treating or coatingwith Heparin or other anticoagulant, an antibiotic, nitric-oxide orother materials, or the like.

The slotted inserter needle 54 is configured to receive a portion of theflexible tubing 10 (including the distal end portion 10 b and distal end10 a) within the central channel of the slotted needle, when theinsertion set device 40 is in the first state (as shown in FIGS. 10 and11). In that arrangement, the slotted inserter needle 54 is slidablerelative to the flexible tubing 10, in the axial direction A, by movingthe inserter 44 in the axial direction, away from the base 42.

When the insertion set device 40 is in the first state (as shown inFIGS. 10 and 11), a distal end portion of the slotted inserter needle 54may be inserted into a patient's skin (or a septum or other structure),a sufficient distance to place the distal end of the flexible tubing 10in the patient (or through the septum or other structure). The slottedinserter needle 54 provides additional rigidity to the distal endportion 10 b of the flexible tubing 10 during insertion, and can have apointed or sharp tip to assist in piercing the patient's skin (or septumor other structure) during insertion.

In addition, the surface 46 of the base 42 of the insertion set device40 may be secured (adhered or otherwise connected) to a surface of thepatient's skin (or a septum or other structure), to hold the base 42onto the patient's skin (or a septum or other structure).

Once the slotted inserter needle 54 containing the distal end portion 10b of the flexible tubing 10 is inserted into (or partially into) thepatient's skin (or a septum or other structure), the slotted inserterneedle 54 may be slid off of the flexible tubing 10, while leaving thedistal end 10 a of the flexible tubing 10 in place in the patient (orthrough the septum or other structure).

In FIG. 12, the insertion set device 40 is shown in transition betweenthe first state (of FIGS. 10 and 11) and the second state (of FIG. 13).In FIG. 12, the inserter 44 has been moved in the axial direction A fromthe base 42 a sufficient distance to have caused the slotted inserterneedle 54 to have slid partially off of the flexible tubing 10. In thatarrangement, the slotted inserter needle 54 has slid off of the distalend portion 10 b of the flexible tubing 10.

When the insertion set device 40 is in the first state (shown in FIGS.10 and 11), and as the slotted inserter needle 54 is being slid off ofthe distal end portion 10 b of the flexible tubing 10 (shown in FIG.12), the second section of the further length portion 10 c of theflexible tubing 10 (forming the bend 10 d) extends out from theslot-shaped opening 56 in the inserter needle 54. With the flexibletubing 10 extending out of the slot-shaped opening 56, the slottedinserter needle 54 is allowed to move in the axial direction A relativeto the flexible tubing 10 along and past the bend 10 d in the flexibletubing 10. Accordingly, the slotted inserter needle 54 may slide off ofthe flexible tubing 10, while the distal end 10 a of the flexible tubing10 remains in place in the patient (or through the septum or otherstructure) and while the other end of the flexible tubing 10 remainsconnected to the coupling 48.

Further movement of the inserter 44 in the axial direction A away fromthe base 42 causes the slotted inserter needle 54 to slide fully off ofthe flexible tubing 10. In that arrangement, the insertion set device 40is in its second state, in which the inserter 44 is fully separated andremoved from the base, as shown in FIG. 13. In the second state, thebase 42 may remain secured to the surface of the patient's skin (or aseptum or other structure) and the distal end portion 10 b of theflexible tubing 10 forms a cannula through the patient's skin (or aseptum or other structure). The inserter 44 may be safely discarded orstored. In other examples, the inserter 44 need not be removed from thebase 42 and may be configured to remain coupled to the base 42 (forexample, in the position shown in FIG. 12), as the second state of theinsertion set device 40.

Either before or after securing the base 42 to the patient's skin (or aseptum or other structure), or before or after sliding the slottedinserter needle 54 relative to the flexible tubing 10, the furthertubing 52 may be connected in fluid flow communication with the coupling48, as described above. Accordingly, the insertion set may be connectedto provide a fluid flow connection between the distal end 10 a of theflexible tubing 10 (within a patient, septum or other structure), and apump or other fluid delivery device or source, sensor, monitor or otherdevice or system connected to the further tubing 52.

The inserter device 40 may be manufactured and assembled by any suitablemanufacturing and assembly processes. An example process 60 in FIG. 16includes providing a base 42 (at 62) and providing an inserter 44 (at64). The base 42 and the inserter 44 may be made by molding, machining,extruding, stamping or other suitable manufacturing processes. Thecoupling 48 may be secured to the base 42 and any other components (suchas, but not limited to, additional support structure for the tubing 10or tube-like structure forming the passage 50) may be formed in orattached to the base 42. The slotted inserter needle 54 may be formed bymolding, machining, extruding, stamping or other suitable manufacturingprocesses, and may be connected to the inserter body 53 as describedabove.

The process 60 further includes installing the distal end portion 10 bof the flexible tubing 10 into the slotted inserter needle (at 65). Thedistal end portion 10 b of the flexible tubing 10 may be installed inthe channel of the slotted inserter needle in any suitable matter,including, but not limited to the matter described with reference toFIG. 15. As shown in FIG. 15, the flexible tubing 10 may be assembledwith the slotted inserter needle 54 by inserting the tubing 10 into theinserter needle 54, for example, through the larger width portion 56 bof the slot-shaped opening 56, and maintaining or pulling a portion ofthe length of the tubing out of the larger width portion 56 b of theslot-shaped opening 56. Then, the portion of the length of the tubingthat has been pulled out of the slot-shaped opening 56 may be grippedand forced in the axial direction A, to pull or push the tubing into thesmaller slot-width portion 56 a of the inserter needle 54, until thedistal end 10 a of the flexible tubing 10 is positioned within thesmaller slot-width portion 56 a of the inserter needle 54 and proximateto the (but not beyond) the distal end 54 a of the needle 54.

The end of the length of the tubing portion that has been pulled out ofthe slot-shaped opening (i.e., the opposite end of the flexible tubing10 relative to the distal end 10 a) is connected to the coupling 48 (at66). The tubing end may be connected to the coupling 48 in any suitablemanner, including, but not limited to inserting the end portion of theflexible tubing into the coupling 48 and adhering the tubing to thecoupling 48 as described above.

Prior to or after coupling the flexible tubing 10 to the coupling 48,the slotted insertion needle 54 (with the distal end portion 10 b of thetubing) is inserted through the passage 50 (at 68). In other examples,other suitable manufacturing and assembly processes may be employed toform the insertion set device 40.

While the size and dimension of the insertion set device 40 and itscomponents may be selected to accommodate the intended application ofuse, certain sizes and dimensions may be appropriate for certain medicaluses. As one example, an insertion set device 40 may include a flexibletubing 10 having a length L of about 6 mm. (or between about 6 mm andabout 9 mm). In addition, the flexible tubing 10 may have an outerradius R of about 0.0045 in. (or about 0.1143 mm) and an L/R ratio andR/r ratio as described above in Table 1, to inhibit kinking or bucklingalong its length dimension. The inserter needle 54 may have a gauge of27 G, or from 26 G to 30 G, or an outer radius R_(N) of about 0.0142 in.(or 0.361 mm) or from 0.01 in. to 0.0159 in. (or 0.25 mm to 0.404 mm).The inserter needle 54 may have a first slot width in the smaller widthportion 56 a of about 0.007 in. (or 0.18 mm), a second slot width in thelarger width portion 56 b of about 0.0095 in. (or 0.24 mm), and a lengthdimension large enough to receive the full length of the distal endportion 10 b of the tubing, and to extend through the base and eitherinto or through the inserter. In certain examples, when the insertionset device is in the first state (with the distal end portion 10 b ofthe tubing located within the inserter needle), the minimum distancebetween the distal end 10 a of the tubing 10 to the start of the needlebevel or taper (of the sharp end of the needle) is about 0.020 inch (or0.508 mm), to avoid or prevent the distal end 10 a of the tubing 10 fromcatching on tissue during insertion. The bevel or taper of the sharp endof the inserter needle 54 may have any suitable length along the lengthdimension of the inserter needle 54, such as, but not limited to about0.040 inch (or 1.016 mm), to reduce or minimize patient trauma duringinsertion. In other examples, the tubing and inserter needle may haveother suitable dimensions.

Another example of an insertion set device 70 having a cannula formedwith or of a flexible tubing 10 (or other suitable tubing) is describedwith reference to FIGS. 17-21. The insertion set device 70 is shown incross-section view in FIG. 17 (corresponding to the cross-section 10-10in FIG. 11). FIG. 18 shows an enlarged view of a portion of FIG. 17identified by the circle labeled 18 in FIG. 17.

The insertion set device 70 may be made and may operate and function asdescribed above with respect to the insertion set device 40, withcertain differences discussed below. The insertion set device 70 has abase 72 and an inserter 74, which may correspond in structure andfunction to the base 42 and inserter 44, respectively, as discussedabove, with certain differences discussed below.

The inserter 74 has a slotted inserter needle 75, which may correspondto the slotted inserter needle 54 described above. However, the slottedinserter needle 75 may include a slot having a constant width along itslength (and need not include two different slot widths, as describedwith respect to the slotted inserter needle 54 shown in FIG. 15). Theslotted inserter needle 75 has a distal end 75 a corresponding to thedistal end 54 a of the slotted inserter needle 54.

In the insertion set device 70, the flexible tubing 10 includes a distalend 10 a and distal end portion 10 b, as discussed above. The distal end10 a and a distal length portion 10 b of the tubing 10 extends out froma first opening 72 a in a surface 76 of the base 72. The first opening72 a and surface 76 may correspond to the first opening 42 a and surface46 of the insertion set device 40 discussed above.

A further length portion 10 c of the tubing 10 is located within thebase 72 and extends from the distal length portion 10 b, to a chamber 78within the base 72. The further length portion 10 c of the tubing 10 hasan end (opposite to the distal end 10 a) that is open to and in fluidflow communication with the chamber 78. The chamber 78 is located inaxial alignment with the tubing 10 and the slotted inserter needle 75.Accordingly, the entire length of the tubing 10 in the insertion setdevice 70 may be normally straight (and need not include a bend 10 d asin the inserter set device 40). However, the distal end portion 10 b ofthe tubing 10 may be flexible when the inserter needle 75 is withdrawn.

The chamber 78 may be a sealed interior volume within the base 72,through which fluid may flow and change flow direction, as describedherein. The chamber 78 may be formed directly within the material of thebase 72. In other examples, the chamber 78 may be the interior of acontainer structure located and fixed within the base 72.

The base 72 has a first needle passage 80 (corresponding to the passage50 in the insertion set device 40), that extends, linearly, from theopening 72 a to the chamber 78. The base 72 also includes a first septum82, located between the chamber 78 and a second opening 72 b in the base72. The second opening 72 b may correspond to the second opening 42 b inthe insertion set device 40. The first septum 82 is made of a materialsuitable to be pierced through by the slotted inserter needle 75, andmay be a self-sealing septum material, such as, but not limited tosilicon, other rubber material, or the like.

When the insertion set device 70 is in a first state, as shown in FIG.17, the slotted inserter needle 75 is extended through the first septum82, the chamber 78 and the needle passage 80. In addition, when theinsertion set device 70 is in a first state, as shown in FIG. 17, theflexible tubing 10 (including the distal end 10 a) is located within thecentral channel of the slotted inserter needle 75, and a distal end 75 aof the slotted inserter needle 75 is located beyond the distal end 10 aof the flexible tubing 10.

The base 72 includes a second needle passage 84 extending linearly andtransverse to the axial dimension A and, thus, transverse to thedirection of first needle passage 80 and the flexible tubing 10. Incertain examples, the second needle passage 84 extends perpendicular tothe axial dimension A. In other examples, the second needle passage 84extends at an angle between about 90° and about 160° (or, in particularexamples, between about 135° and about) 160° relative to the axialdimension A. The second needle passage 84 may be formed directly withinthe material of the base 72 (such as, by boring, molding or otherwiseforming a channel through the material of the base). In other examples,the second needle passage 84 may be the interior of a tube structureincluded in and fixed to the base 72. The second needle passage 84 hasan open end 84 a, opening to the exterior of the base 72.

A second septum 86 is located in the second needle passage 84, orbetween the second needle passage 84 and the chamber 78. The secondseptum 86 is made of a material suitable to be pierced through by afurther needle 88, and may be a self-sealing septum material, such as,but not limited to materials as described above with respect to thefirst septum 82. The further needle 88 may be a hollow needle forcoupling a further tubing 90 in fluid flow communication with thechamber 78 in the base 72. The further tubing 90 may correspond to thefurther tubing 52 connected to the insertion set device 40, and mayconnect the insertion set device 70 to other devices and systems asdescribed herein with respect to the further tubing 52.

As shown in FIG. 17, the further needle 88 extends through the secondneedle passage 84 and through the second septum 86. The further needle88 has a first end (such as a sharp or pointed end) 88 a, located withinthe chamber 78, and a second end 88 b, located in the further tubing 90.The further tubing 90 may be coupled and sealed to the further tubing90, and has a central passage providing a fluid flow path between thefurther tubing 90 and the chamber 78 in the base 72.

In particular examples, the further needle 88 and the second septum 86provide a connector structure that allows the further tubing 90 to beselectively connected or disconnected from the base 72. For example, thefurther needle 88 may be moved from a position in which the distal end88 a of the further needle 88 is fully outside of the second needlepassage 84, to a connected position shown in FIG. 17, by moving theneedle 88 through the second needle passage 84 in the direction of arrow92, until the distal end 88 a of the needle 88 pierces through thesecond septum 86 and is located within the chamber 78. From thatposition, the further needle 88 may be withdrawn from the second septum86 and from the base 72, by moving the needle 88 along the second needlepassage 84, in a direction opposite to the direction of arrow 92, toselectively disconnect the further tubing 90 from the chamber 78 andfrom the base 72. Other examples may have other suitable couplingstructures for coupling the further tubing 90 to the chamber 78 and thebase 72, including but not limited to the coupling devices describedabove with respect to coupling 48.

In the insertion set device 70, one or more additional features may beprovided to hold the flexible tubing 10 within the first needle passage80, in a fixed relation to the base 72. In certain examples, a collarstructure 92 may be provided within the first needle passage 80, to holdthe flexible tubing 10 in a fixed relation to the base 72. The collarstructure 92 may be adhered to the flexible tubing 10 and to the base 72by any suitable mechanism, including but not limited to frictionfitting, adhesives, welds, or the like.

The collar structure 92 may be made of a material suitable to be piercedthrough by the slotted inserter needle 75, and may be a self-sealingseptum material, such as, but not limited to materials as describedabove with respect to the first septum 82. When the insertion set device70 is in the first state shown in FIG. 17, the slotted inserter needle75 is pierced through the collar structure 92 and contains the flexibletubing 10 within its central channel, as shown in the cross-sectiondrawing of FIG. 19 (taken perpendicular to the axial dimension A, withinthe base 72, below the chamber 78). In certain examples, the collarstructure 92 may extend around some, but not the entire circumference ofthe tubing 10, without covering a surface portion 10 e of the tubing 10that is exposed through the slot shaped opening of the inserter needle75, as shown in FIG. 19. In certain examples, additional adhesivematerial, welding or the like may be provided along the surface 10 e ofthe flexible tubing 10, to adhere the surface 10 e of the tubing 10 tothe base 72. The collar structure 92 or the additional adhesive orwelding retains and holds the flexible tubing 10 to the base 72, as andafter the slotted inserter needle 75 is withdrawn and slid off of theflexible tubing 10. In other examples, other suitable structure may beprovided for fixing the flexible tubing 10 to the base 72.

The insertion set device 70 is shown in FIGS. 20 and 21, in a secondstate, in which the inserter 74 (including the slotted inserter needle75) has been fully withdrawn from the base 72. The drawing in FIG. 21shows the cross-section view of FIG. 19, but with the slotted inserterneedle 75 removed from the collar structure 92, where the collarstructure 92 is made of a self-sealing material that has sealed afterremoval of the needle 75.

Another example of an insertion set device 100 having a cannula formedwith or of a flexible tubing 10 (or other suitable tubing) is describedwith reference to FIGS. 22-25. In FIGS. 23 and 25, the insertion setdevice 100 is shown in cross-section views (corresponding to thecross-section 10-10 in FIG. 11), in the first state and the secondstate, respectively. FIG. 23 shows an enlarged view of a portion of FIG.22 identified by the circle labeled 23, and FIG. 24 shows a furtherenlarged view of features of the insertion set device 100.

The insertion set device 100 may be made and may operate and function asdescribed above with respect to the insertion set devices 40 and 70,with certain differences discussed below. The insertion set device 100has a base 102 and an inserter 104, which may correspond in structureand function to the base 42 (or base 72) and inserter 44 (or inserter74), respectively, as discussed above, with certain differencesdiscussed below. The base 102 includes a needle passage 103(corresponding to the needle passage 50 in the insertion set device 40).

The inserter 104 has a slotted inserter needle 105, which may correspondto the slotted inserter needle 54 (or 75) described above. However, theslotted inserter needle 105 may include a slot having a constant widthalong its length (and need not include two different slot widths, asdescribed with respect to the slotted inserter needle 54 shown in FIG.15). The slotted inserter needle 105 has a distal end 105 acorresponding to the distal end 54 a (or 75 a) of the slotted inserterneedle 54 (or 75).

In the insertion set device 100, the flexible tubing 10 includes adistal end 10 a and distal end portion 10 b, as discussed above. Thedistal end 10 a and a distal length portion 10 b of the tubing 10extends out from a first opening 102 a in a surface 106 of the base 102.The first opening 102 a and surface 106 may correspond to the firstopening 42 a and the surface 46 of the insertion set device 40 discussedabove (or the first opening 72 a and the surface 76 of the insertion setdevice 70 discussed above).

A further length portion 10 c of the tubing 10 is located within theneedle passage 103 in the base 102 and extends from the distal lengthportion 10 b, to a holding pin that may be a rigid wire or stopstructure 108 within the base 102. The further length portion 10 c ofthe tubing 10 has an end (opposite to the distal end 10 a) that isabutted against the rigid wire or stop structure 108. In the example ofFIG. 23, the rigid wire or stop structure 108 has an elongated wire orshaft shape with a distal end portion 108 a and a bent portion 108 badjacent the distal end portion 108 a. The distal end portion 108 a mayextend partially into the second end of the tubing 10 opposite to thedistal end 10 a. Alternatively, the distal end portion 108 a may contactthe end of the tubing 10, without extending into the tubing 10.

The rigid wire or stop structure 108 has a length section that extendswithin the base 102, and is fixed to the base 102. The rigid wire orstop structure 108 may be molded into the base, or may be fixed to thebase 102 by any other suitable mechanism, including but not limited tofriction fitting, adhesives, welds, or the like. The rigid wire or stopstructure 108 holds and retains the flexible tubing 10 in the base andkeeps the flexible tubing 10 from moving with the slotted inserterneedle 105, as the slotted inserter needle 105 is withdrawn from thebase 102. The bent portion 108 b of the rigid wire or stop structure 108extends out from the slot-shaped opening in the slotted inserter needle105, when the insertion set device 100 is in the first state shown inFIG. 22, and as the slotted inserter needle 105 is being withdrawn fromthe base 102.

The base 102 includes a hollow tube structure 110 having a first end 110a connected in fluid flow communication with the further length portion10 c of the tubing 10. In one example, the end 110 a of the tubestructure 110 is inserted partially into the side of the further lengthportion 10 c of the flexible tubing 10. The tube structure 110 extendsthrough the slot-shaped opening in the slotted inserter needle 105, whenthe insertion set device 100 is in the first state shown in FIG. 22, andas the slotted inserter needle 105 is being withdrawn from the base 102.The tube structure 110 provides a fluid flow passage to or from theflexible tubing 10. In certain examples, the tube structure 110 may havean oval or widened cross-section shape (as shown in the further view ofFIG. 24), to provide a greater fluid flow volume, relative to a tubestructure having a round cross-section that would fit through theslot-shaped opening in the slotted inserter needle 105.

The hollow tube structure 110 may have a second end 110 b connected influid flow communication with a coupling 112. The coupling 112 maycorrespond to the coupling 48 of the insertion set device 40, or anothersuitable fluid coupling device, for coupling a further tubing 114 to thebase 102, in fluid flow communication with the tube structure 110. Thefurther tubing 114 may correspond to the further tubing 52 or thefurther tubing 90 discussed above.

The hollow tube structure 110 extends from the further length portion 10c of the tubing 10 to the coupling 112. The length dimension of thehollow tube structure 110 may extend linearly and transverse to axialdimension A of the tubing 10, such that the height H in the axialdimension of the base 102 (dimension between the surface 106 and theopposite facing surface) may be made relatively small or minimized. Incertain examples, the hollow tube structure 110 extends at about 90°relative to the axial dimension, such that the coupling 112 is directedabout 90° from the direction of distal length portion 10 b of the tubing10. This arrangement allows the further tubing 114 to be connected tothe coupling 112, external to the base 102, and extend outward from thebase 102, substantially parallel to and along the surface of thepatient's skin (or other surface) to which the base 102 secures.Accordingly, the base 102 and tubing 10 may be more easily concealedunder clothing or the like. In other examples, the hollow tube structure110 may extend at an angle between about 90° and about 160° (or, inparticular examples, between about 135° and about 160°), relative to theaxial dimension A.

Another example of an insertion set device 120 having a cannula formedwith or of a flexible tubing 10 (or other suitable tubing) is describedwith reference to FIGS. 26-29. In FIGS. 26 and 29, the insertion setdevice 120 is shown in cross-section views (corresponding to thecross-section 10-10 in FIG. 11), in the first state and the secondstate, respectively. FIG. 27 shows an enlarged view of a portion of FIG.26 identified by the circle labeled 27 in FIG. 26, and FIG. 28 shows afurther enlarged view of features of the insertion set device 120.

The insertion set device 120 may be made and may operate and function asdescribed above with respect to the insertion set device 100, withcertain differences discussed below. The insertion set device 120 has abase 122 and an inserter 124, which may correspond in structure andfunction to the base 102 (or bases 42 or 72) and inserter 104 (orinserters 44 or 74), respectively, as discussed above, with certaindifferences discussed below. The base 122 includes a needle passage 123(corresponding to the needle passage 103 in the insertion set device100).

The inserter 124 has a slotted inserter needle 125, which may correspondto the slotted inserter needle 105 (or 54 or 75) described above. Theslotted inserter needle 125 may include a slot having a constant widthalong its length (and need not include two different slot widths, asdescribed with respect to the slotted inserter needle 54 shown in FIG.15). The slotted inserter needle 125 has a distal end 125 acorresponding to the distal end 105 a (or 54 a or 75 a) of the slottedinserter needle 105 (or 54 or 75).

In the insertion set device 120, the flexible tubing 10 includes adistal end 10 a and distal end portion 10 b, as discussed above. Thedistal end 10 a and a distal length portion 10 b of the tubing 10extends out from a first opening 122 a in a surface 126 of the base 122.The first opening 122 a and surface 126 may correspond to the firstopening 102 a and the surface 126 of the insertion set device 100.

A further length portion 10 c of the tubing 10 is located within theneedle passage 123 in the base 122 and extends from the distal lengthportion 10 b, to a rigid, hollow tube 128 within the base 122. Thefurther length portion 10 c of the tubing 10 has an end (opposite to thedistal end 10 a) that is abutted against the rigid tube 128. In theexample of FIG. 26, the rigid tube 128 has an elongated tubular shapewith a distal end portion 128 a and a bent portion 128 b adjacent thedistal end portion 128 a. The distal end portion 128 a may extendpartially into the second end of the tubing 10 opposite to the distalend 10 a. Alternatively, the distal end portion 128 a may connect to theend of the tubing 10 through a fluid flow connector, without extendinginto the tubing 10.

The hollow, rigid tube 128 has a length section that extends within thebase 122 (between the bent portion 128 b and a second end 128 c), and isfixed to the base 122. The rigid tube 128 may be molded into the base122, or may be fixed to the base 122 by any other suitable mechanism,including but not limited to friction fitting, adhesives, welds, or thelike. The rigid tube 128 holds and retains the flexible tubing 10 in thebase and keeps the flexible tubing 10 from moving with the slottedinserter needle 125, as the slotted inserter needle 125 is withdrawnfrom the base 122. The bent portion 128 b of the rigid tube 128 extendsout from the slot-shaped opening in the slotted inserter needle 125,when the insertion set device 120 is in the first state shown in FIG.26, and as the slotted inserter needle 125 is being withdrawn from thebase 122.

The hollow, rigid tube 128 has a fluid flow channel that provides afluid flow path between the tubing 10 and a further tubing 130. Thefurther tubing 130 may correspond to the further tubing 114, 90 or 52discussed above. The further tubing 130 may be connected in fluid flowcommunication with a second end 128 c of the hollow, rigid tube 128(opposite to the distal end portion 128 a) within the base 122 (as shownin FIGS. 26 and 29), or outside of the base 122. For example, a portionof the hollow, rigid tube 128 and the second end 128 c may extend intothe further tubing 130 and be sealed and adhered to the further tubing130 by any suitable mechanism, including, but not limited to adhesives,welding or the like. Alternatively, the hollow, rigid tube 128 may beconnected in fluid flow communication with the further tubing throughany suitable in-line or other fluid flow coupling device, such as, butnot limited to a Luer Lok™ device, Luer™-slip device, slip tip device,hollow needle and septum configuration or the like.

The hollow, rigid tube 128 may have a round cross-section shape (takenperpendicular to its length dimension), and may be made of any suitable,rigid material such as, but not limited to stainless steel or othermetal, plastic, ceramic, composite material, or the like. The hollow,rigid tube 128 may be made by any suitable manufacturing processincluding, but not limited to molding, machining, extruding, stamping orother the like.

The hollow, rigid tube 128 has a length section 128 d that extendswithin the base 122 between the bent portion 128 b and a second end 128c. Due to the bent portion 128 b, the length section 128 d of thehollow, rigid tube 128 may extend linearly and transverse to axialdimension A of the tubing 10, such that the height H in the axialdimension of the base 122 (dimension between the surface 106 and theopposite facing surface) may be made relatively small or minimized. Incertain examples, the length section 128 d of the hollow, rigid tube 128extends at about 90° relative to the axial dimension. This arrangementallows the further tubing 130 to be connected and extend outward fromthe base 122, substantially parallel to and along the surface of thepatient's skin (or other surface) to which the base 122 secures.Accordingly, the base 122 and tubing 10 may be more easily concealedunder clothing or the like. In other examples, the length section 128 dof the hollow, rigid tube 128 may extend at an angle between about 90°and about 160° (or, in particular examples, between about 135° and about160°), relative to the axial dimension A.

Another example of an insertion set device 140 having a cannula formedwith or of a flexible tubing 10 (or other suitable tubing) is describedwith reference to FIGS. 30-32. In FIG. 30, the insertion set device 140is shown in a cross-section view (corresponding to the cross-section10-10 in FIG. 11), in the first state. FIG. 31 shows an enlarged view ofa portion of FIG. 30 identified by the circle labeled 31, and FIG. 32shows a further enlarged view of features of the insertion set device140.

The insertion set device 140 may be made and may operate and function asdescribed above with respect to the insertion set device 70, withcertain differences discussed below. The insertion set device 140 has abase 142 and an inserter 144, which may correspond in structure andfunction to the base 72 and inserter 74, respectively, as discussedabove, with certain differences discussed below. The base 142 includes aneedle passage 143 (corresponding to the needle passage 80 in theinsertion set device 70).

In the insertion set device 140, the flexible tubing 10 includes adistal end 10 a and distal end portion 10 b, as discussed above. Thedistal end 10 a and a distal length portion 10 b of the tubing 10extends out from a first opening 142 a in a surface 146 of the base 142.The first opening 142 a and surface 146 may correspond to the firstopening 72 a and the surface 76 of the insertion set device 70. Afurther length portion 10 c of the tubing 10 is located within theneedle passage 143 in the base 142 and extends from the distal lengthportion 10 b, to a chamber 148 (corresponding to the chamber 78 in theinsertion set device 70). The insertion set device 140 also includes afirst septum 152, a second needle passage 154 and a second septum 156(corresponding to the first septum 82, the second needle passage 84 andthe second septum 86 in the insertion set device 70). In addition, theinsertion set device 140 may be configured to connect with a furtherneedle 88 and a further tubing 90, as discussed above with respect tothe insertion set device 70.

The inserter 144 has a hollow inserter needle 145 that has a centralchannel extending along its entire length. In some examples, theinserter needle 145 may correspond to the slotted inserter needle 75described above. However, in other examples, the inserter needle 145need not be slotted and, instead, may have a hollow, fully roundcylindrical configuration. In addition, the inserter needle 145 isconfigured to be received by and selectively removable from a bodyportion 147 of the inserter 144. The body portion 147 of the inserter144 may correspond to the body portion of the inserter 74 (and theinserter body 53) described above, but includes a needle passage 150extending linearly through the body portion 147. The needle passage 150is arranged to be in linear alignment with the needle passage 143 in thebase 142 and is coaxial with the axis A of the tubing 10, when theinsertion set device 140 is in the first state as shown in FIG. 30.

The insertion set device 140 also includes a removable holding pin 160having a first end 160 a and an opposite second end 160 b. When theinsertion set device 140 is in the first state (as shown in FIGS. 30 and31), the holding pin 160 is received within, and extends along a portionof the length of the hollow inserter needle 145, but is removable fromthe hollow inserter needle 145 by sliding out of the channel of theneedle 145, along a direction of the axis A.

In that first state, the tubing 10 is also received with and extendsalong another portion of the length of the hollow inserter needle 145.The holding first end 160 a of the holding pin 160 is arranged to abutthe second end of the tubing 10 (opposite to the distal end 10 a),within the channel of the hollow inserter needle 145, while the secondend 160 b of the holding pin 160 is exposed (for example, by extendingout from an opening 147 a in the inserter body portion 147) at an end ofthe needle passage 150. In certain examples, the holding pin 160 mayextend partially into the second end of the tubing 10. In otherexamples, the holding pin 160 contacts, but does not enter the tubing10. The opening 147 a in the inserter body portion 147 may be flared soas to taper wider from the width of the needle passage 150 to a widerwidth at the open end of the opening 147 a, for easier access to thehollow inserter needle 145.

The insertion set device 140 may include a collar structure 162 withinthe needle passage 143 and around the length portion 10 c of the tubing10, to help retain the tubing 10 within and fixed to the base 142, whenthe inserter needle 145 and the holding pin 160 are removed. The collarstructure 162 may be made of a material suitable to be pierced throughby the hollow inserter needle 145, and may be a self-sealing septummaterial, such as, but not limited to materials as described above withrespect to the collar structure 92 described above. The collar structure162 may be adhered to the flexible tubing 10 and to the base 142 by anysuitable mechanism, including but not limited to friction fitting,adhesives, welds, or the like.

When the insertion set device 140 is arranged in the first state (asshown in FIGS. 30 and 31), the entire length of the tubing 10 and aportion of the length of the holding pin 160 are received within thechannel of the hollow inserter needle 145. In addition, the holding pin160 abuts the tubing 10, to retain and hold the tubing 10 from movingwith the hollow inserter needle 145, when the hollow inserter needle 145is being withdrawn.

In that first state, the insertion set device 140 may be inserted orinstalled on a patient, septum or other device, and the further tubing90 may be connected to the base 142 (similar to the manner of installingdevices in examples of FIGS. 10-29, as described above)

After insertion or installation of the insertion set device 140, thehollow inserter needle 145 is withdrawn from the base 142 and inserter144, by moving the hollow needle in the direction of the axis A, awayfrom the inserter 144. For example, a user (or tool or machine) may gripthe hollow inserter needle 145 near the end 145 b, and may pull thehollow inserter needle 145 outward (upward in FIG. 30) along thedirection of the axis A of the needle passages 143 and 150 and of thetubing 10, to withdraw the hollow needle from the base 142 and theinserter 144. At the same time, the holding pin 160 remains abutted withthe tubing 10, to retain the tubing 10 within the base 142, and keep thetubing 10 from moving with the hollow inserter needle 145, as theinserter needle is withdrawn.

Once the hollow inserter needle 145 has been fully withdrawn, theholding pin 160 may be withdrawn by moving the holding pin 160 in thedirection of the axis A, away from the inserter 144. For example, a user(or tool or machine) may grip the holding pin 160, near the exposedsecond end 160 b, and may pull the holding pin 160 outward (upward inFIG. 30) along the direction of the axis A of the needle passage 150,away from the tubing 10, to withdraw the holding pin 160 from the base142 and the inserter 144. At the same time, the tubing 10 remainsretained within and fixed to the base 142, by the collar structure 162.Accordingly, the insertion set device 140 is transitioned to the secondstate (as shown in FIG. 32), after the inserter needle 145 and theholding pin 160 have been withdrawn.

While various exemplary embodiments have been presented in the foregoingdetailed description, it should be appreciated that a vast number ofvariations exist. It should also be appreciated that the exemplaryembodiment or embodiments described herein are not intended to limit thescope, applicability, or configuration of the claimed subject matter inany way. Rather, the foregoing detailed description will provide thoseskilled in the art with a convenient road map for implementing thedescribed embodiment or embodiments. It should be understood thatvarious changes can be made in the function and arrangement of elementswithout departing from the scope defined by the claims, which includesknown equivalents and foreseeable equivalents at the time of filing thispatent application.

We claim:
 1. An insertion set system comprising: a base configured to besecured externally to a patient; a flexible tubing supported by the baseand having a distal end portion located external to the base, the distalend portion forming a cannula that is configured to be inserted into thepatient, when or while the base is secured externally to the patient;and an inserter having a needle, the needle having a needle channelwithin the needle in which at least the distal end portion of theflexible tubing is received such that the distal end portion of theflexible tubing is located within the needle, the needle being able toslide relative to the flexible tubing, to selectively withdraw theneedle off of at least the distal end portion of the flexible tubing. 2.The insertion set system of claim 1, wherein the needle and the flexibletubing are in a first state in which at least the distal end portion ofthe flexible tubing is received in the needle channel, and wherein theneedle is moveable along a length dimension of the distal end portion ofthe flexible tubing to a second state in which the needle is separatedfrom the distal end portion of the flexible tubing.
 3. The insertion setsystem of claim 1, further comprising a fluid coupling, wherein theflexible tubing has a second end opposite the distal end portion, andwherein the second end of the flexible tubing is connected in fluid flowcommunication with the fluid coupling.
 4. The insertion set system ofclaim 3, wherein: the needle of the inserter having a length dimensionand a slot-shaped opening extending along at least a portion of thelength dimension, the slot-shaped opening being open to the needlechannel; the flexible tubing includes a length portion extending fromthe distal end portion to the second end of the flexible tubing, thelength portion extending out of the needle channel, through theslot-shaped opening of the needle.
 5. The insertion set system of claim4, wherein the length portion of the flexible tubing that extends out ofthe needle channel has a bend of between 90° and 160°.
 6. The insertionset system of claim 4, wherein the slot shaped opening in the needle hasa first width extending from a distal end of the needle, along a firstportion of the length dimension of the needle, and a second widthextending along a second portion of the length dimension of the needle,the second width being larger than the first width.
 7. The insertion setsystem of claim 1, wherein: the distal end portion of the flexibletubing has a length extending along an axial dimension of the flexibletubing; the base has a chamber in fluid flow communication with theflexible tubing; and the base has a fluid flow channel extendingtransverse to the axial dimension.
 8. The insertion set system of claim7, wherein the channel in the base extends from the chamber at an angleof between 90° and 160° relative to an axial dimension of the distal endportion of the flexible tubing.
 9. The insertion set system of claim 7,further comprising a first septum on the base, at a location inalignment with the axial dimension of the flexible tubing and thechamber, wherein the needle extends through the first septum and thechamber, when the distal end portion of the flexible tubing is receivedin the needle channel.
 10. The insertion set system of claim 9, furthercomprising a second septum located in the channel of the base or betweenthe channel of the base and the chamber, the second septum configured tobe pierced by a further needle for connection of a further tubing to thechannel of the base.
 11. The insertion set system of claim 7, wherein:the flexible tubing has a further length portion extending from thedistal end portion into the base; the base includes a tubing channelthrough which the further length portion of the flexible tubing extends,and a collar fixing the further length portion of the flexible tubing tothe base within the needle channel of the base, wherein the needle ispierced through the collar when the distal end portion of the flexibletubing is received in the needle channel.
 12. The insertion set systemof claim 7, wherein: the flexible tubing has a further length portionextending from the distal end portion into the base; the insertion setsystem further comprising a holding pin arranged and configured to abutan end portion of the further length portion of the flexible tubing andinhibit movement of the flexible tubing with the needle while the needleis being withdrawn off of the distal end portion of the flexible tubing,the holding pin being moveable away from the end portion of the furtherlength of the flexible tubing, after the needle has been withdrawn offof the distal end portion of the flexible tubing.
 13. The insertion setsystem of claim 1, wherein: the distal end portion of the flexibletubing has a length extending along an axial dimension of the flexibletubing; the flexible tubing has a further length portion extending fromthe distal end portion into the base; and the insertion set systemfurther comprising a holding pin arranged and configured to abut an endportion of the further length portion of the flexible tubing and inhibitmovement of the flexible tubing with the needle while the needle isbeing withdrawn off of the distal end portion of the flexible tubing.14. The insertion set system of claim 13, wherein the holding pincomprises a rigid wire or stop structure that is fixed to the base. 15.The insertion set system of claim 13, wherein: the needle of theinserter has a length dimension and a slot-shaped opening extendingalong at least a portion of the length dimension, the slot-shapedopening being open to the needle channel; and the holding pin extendsout of the needle channel, through the slot-shaped opening of theneedle.
 16. The insertion set system of claim 1, wherein: the flexibletubing has a further length portion extending from the distal endportion into the base; the insertion set system further comprising arigid hollow tube connected in fluid flow communication with an endportion of the further length portion of the flexible tubing andabutting the end portion of the further length portion of the flexibletubing to inhibit movement of the flexible tubing with the needle whilethe needle is being withdrawn off of the distal end portion of theflexible tubing.
 17. The insertion set system of claim 16, wherein: theneedle of the inserter has a length dimension and a slot-shaped openingextending along at least a portion of the length dimension, theslot-shaped opening being open to the needle channel; and the rigidhollow tube has a length portion that extends out of the needle channel,through the slot-shaped opening of the needle.
 18. The insertion setsystem of claim 16, wherein the rigid hollow tube is fixed to the baseand is configured to be connected in fluid flow communication with afurther tubing located at least partially external to the base.
 19. Theinsertion set of claim 1, wherein the needle comprises a structure madeof a material having sufficient rigidity to pierce skin of the patient,the needle structure having a hollow interior that defines the channelwithin the needle and in which the distal end portion of the flexibletubing is located.
 20. The insertion set of claim 1, wherein the basehas a surface that is configured to be secured to the patient, externalto the patient's skin.
 21. The insertion set of claim 1, wherein thebase has a surface on which an adhesive is provided, for securing thebase to a patient's skin.
 22. The insertion set of claim 1, wherein theneedle extends through the base when the distal end portion of theflexible tubing is located within the needle.
 23. An insertion setsystem, comprising: a base configured to be secured to a patient; aflexible tubing supported by the base and having a distal end portionlocated external to the base, the distal end portion forming a cannulathat is configured to be inserted into the patient, when or while thebase is secured to the patient; and an inserter having a needle, theneedle having a needle channel in which at least the distal end portionof the flexible tubing is received, the needle being able to sliderelative to the flexible tubing, to selectively withdraw the needle offof at least the distal end portion of the flexible tubing; wherein: theflexible tubing has a further length portion extending from the distalend portion into the base; and the base includes a tubing channelthrough which the further length portion of the flexible tubing extends,and a collar fixing the further length portion of the flexible tubing tothe base within the needle channel of the base, wherein the needle ispierced through the collar when the distal end portion of the flexibletubing is received in the needle channel.
 24. A method of making aninsertion set system comprising: providing a base configured to besecured externally to a patient; supporting a flexible tubing supportedby the base, with a distal end portion of the flexible tubing locatedexternal to the base, the distal end portion forming a cannula that isconfigured to be inserted into the patient, when or while the base issecured to the patient; receiving by the base, an inserter having aneedle, the needle having a needle channel within the needle; receivingat least the distal end portion of the flexible tubing in the needlechannel within the needle for sliding movement, wherein the needle isable to slide relative to the flexible tubing, to selectively withdrawthe needle off of at least the distal end portion of the flexibletubing.